2D barcode requirements for unique device identification (UDI) pertaining to EU MDR compliance is on the horizon for most instrument manufacturers. To be compliant to these new regulations, manufacturers must verify that they can mark a readable data matrix that grades in accordance with the requirements of ISO 15415/GS1 General Specifications using a validated bar code verifier.
The process involves the validation of the verifier unit, the review and grouping of affected materials and the internal validation of existing part marking processes. In addition, each material and surface treatment has its own critical parameters that must be considered. Metal Craft is prepared to implement 2D bar code direct part marking (DPM) through rigorous testing and qualification. We will share our experience and overview of the implementation.
Speakers: Dustin Norton, Business Development Account Manager; and Marc Mysliwiec, Business Development Account Manager, Metal Craft Machine & Engineering